Actively Recruiting
Dual-target BCMA-CD19 CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration
Led by Beijing GoBroad Hospital · Updated on 2025-11-26
18
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
S
Shanghai Liquan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - CD19 CAR-T cell therapy. The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and CD19 CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the infusion of BCMA-CD19 CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the infusion. It is expected that no more than 18 participants will be recruited.
CONDITIONS
Official Title
Dual-target BCMA-CD19 CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and have good compliance
- Aged between 18 and 75 years old
- Diagnosed with relapsed or refractory multiple myeloma with measurable extramedullary lesions
- Positive for BCMA in bone marrow, cerebrospinal fluid tumor cells, or tumor tissue
- Adequate organ functions including cardiac, liver, renal, coagulation, oxygen saturation, and pulmonary function
- Female participants of childbearing age must have a negative pregnancy test before treatment; male participants agree to use contraception for 1 year after treatment
- ECOG score of 2 or less
- Expected survival time longer than 3 months
You will not qualify if you...
- Pregnant or breastfeeding women
- Active infections not effectively controlled
- Active autoimmune diseases not effectively controlled
- Unresolved adverse reactions from previous treatments above grade 1
- Active graft-versus-host disease in allogeneic transplant patients
- Positive for HBV, HCV with detectable viral load, syphilis antibody, or HIV antibody
- Allergic or intolerant to fludarabine or cyclophosphamide
- Symptomatic non-plasma cell central nervous system diseases
- Uncontrolled cardiovascular or cerebrovascular diseases within 6 months, including severe heart failure, recent heart attack or surgery, serious arrhythmias, or severe cardiomyopathy
- History of untreated malignancies within past 5 years or concurrent untreated malignancies
- Inability or unwillingness to comply with study requirements
- Previous use of CAR-T therapy with the same structure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Liquan Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yao Yao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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